At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 236 enrolled
Drug / intervention
CoQ10 & Vitamin E +1 moredietary
Likely dose
Not stated in record
Key inclusion· 8
- ✓Female patient with primary breast cancer diagnosis
- ✓Planned adjuvant chemotherapy (neoadjuvant chemotherapy is excluded)
- ✓Hemoglobin >11 g/dL
- ✓Total cholesterol >160 mg/dL
Key exclusion· 9
- ✕Male breast cancer patients
- ✕Current or planned statin therapy during study
- ✕Current or planned use of corticosteroids for fatigue (except as part of chemotherapy regimen)
- ✕Current or planned use of amphetamines or stimulants (methylphenidate, modafinil) for fatigue
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Double-Blind Placebo-Controlled Study Of Oral Coenzyme Q10 To Relieve Self-Reported Cancer Treatment Related Fatigue In Breast Cancer Patients
In Brief
A Phase 1 clinical trial evaluating CoQ10 & Vitamin E and Placebo & Vitamin E for Breast Cancer and Fatigue. Completed, enrolled 236 participants across 31 sites.
Detailed Summary
RATIONALE: Coenzyme Q10 is a vitamin that may be effective in relieving fatigue and depression in women who are undergoing chemotherapy for breast cancer. PURPOSE: This randomized clinical trial is studying how well coenzyme Q10 works in relieving treatment-related fatigue in women with breast cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Fatigue
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2004
First PostedNov 2004
Primary CompletionAug 2009
TodayJul 2026
First PostedNov 9, 2004
Enrollment StartAug 27, 2004
Primary CompletionAug 31, 2009
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 21.6 years ago
Interventions
CoQ10 & Vitamin Edietary
Placebo & Vitamin Edietary